A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was
temporarily suspended based on review of the data from the first 13 participants and a high
rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the
study data on September 20, 2013 and reported no safety concerns. The high rate of early
discontinuation is inconsistent with the treatment duration required for testing the study
primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the
lenalidomide only arm.

Inclusion Criteria:

- Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder
or therapy-related AML

- Male or female subjects aged ≥ 65

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

- White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

Exclusion Criteria:

- Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide

- Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted
therapy agents.

- Suspected or proven acute promyelocytic leukemia

- Prior bone marrow or stem cell transplantation

- Candidate for allogeneic bone marrow or stem cell transplantation

- AML antecedent hematologic disorder such as chronic myelogenous leukemia or
myeloproliferative neoplasms

- Presence of malignant disease within the previous 12 months with exceptions